Download Smith & Nephew RENASYS Negative Pressure Wound Therapy

Alberta Health Services, news and recommendations about clinical equipment and products.
EQUIPMENT & PRODUCT INFORMATION
RENASYS Negative Pressure Wound Therapy
(NPWT) System and Kits
Issue
Medigas reports that Smith & Nephew is issuing amended User Manuals
for RENASYS pumps (Go, EZ Plus, and EZ Max models) and
Instructions for Use (IFU) for all RENASYS Foam Dressing and Gauze
Dressing Kits, to re-emphasize the importance of patient monitoring
requirements during therapy.
Action
10 April 2015
Information

ZONES/Sites
Clinical Areas Affected:
NORTH ZONE
ALL sites
EDMONTON ZONE
ALL sites
CENTRAL ZONE
ALL sites
CALGARY ZONE
Foothills Medical Centre
South Health Campus
SOUTH ZONE
Brooks Health Centre
Medicine Hat Regional Hospital
ALL clinical areas (including
Community Services, Home
Care, Seniors Health, Long
Term Care, Ambulatory
Care)
Contact:
Ensure all users and potential users are aware.
Review and follow the amendments to User Manuals and IFU (vendor
notice, pp. 1-2, and Manual and IFU attachments). These include, but are
not limited to, patient monitoring, and lack of blockage or leak alarms:
Carefully monitor the patient, device and dressing frequently for
bleeding, exudate accumulation (pooling), infection, maceration, or loss
of therapy.
Do not rely solely on the device alarms that therapy is being
delivered effectively or that bleeding or pooling is not occurring. Pay
special attention to risks of bleeding and loss of therapy when
considering home use.
Be aware of other important factors that may impact therapy
and/or safety, including port alignment, exudate characteristics,
canister orientation, tubing height, removal of wound filler, skin grafts.
Be aware of circumstances that can prevent alarms for blockages or
leaks.
Review your inventory for RENASYS pumps and kits. Update the User
Manual (for pumps), and IFU (for kits) for any items currently in your
area, by printing the relevant attachments. You may also request copies
from Smith & Nephew at 1-800-876-1261. Pumps and kits will be shipped
with updated Manuals and IFU from the manufacturer, going forward.
Complete and return the Medigas Acknowledgement form to
[email protected] or fax 1-416-365-0092 (vendor notice, p. 4,
attached).
Complete and return the attached E&P Advisory Response Form to
[email protected] or fax# 403-955-9981.
If you are not a user of these products, no response is required.
Holly Meyer, MSc,
Director - AHS Product Quality and Safety,
Phone: 403-955-9923
[email protected]
Wound Management
Smith & Nephew Inc.
2280 Argentia Road
Mississauga, Ontario
L5N 6H8 Canada
T 905 813 7770
F 905 813 7775
www.smith-nephew.com
February 26, 2015
DEVICE CORRECTION
RENASYS™ Devices
Amended User Manuals / Instructions for Use
Dear Customer:
Following a recent review of post marketing surveillance information regarding our RENASYS range of Negative
Pressure Wound Therapy (NPWT) devices, Smith & Nephew is issuing a Device Correction Notice to announce
the implementation of amended User Manuals for the RENASYS Go (66800164), RENASYS EZ Plus (66800697)
and RENASYS EZ Max (66801309) devices and amended Instructions for Use (“IFU”) for the RENASYS Foam &
Gauze Dressing Kits to re-emphasize the importance of patient monitoring requirements during negative
pressure wound therapy.
PLEASE NOTE THAT THIS CORRECTION DOES NOT REQUIRE ANY RETURN OF RENASYS NPWT PRODUCTS.
The User Manuals / IFU amendments will remind customers that the dressing is to be checked regularly to
ensure that pooling is not occurring beneath the dressing and remind users not to rely solely on the device
alarms to ensure that therapy is being effectively delivered. The essential elements of the revised User Manuals
/ IFU are provided in this letter and the amended User Manuals / IFU are available upon request.
The revised User Manuals / IFU will include the following “Important information” section:
Important information
Monitoring NPWT
Carefully monitor the patient, device and dressing frequently, to determine if there are any signs of bleeding,
exudate accumulation (pooling), infection, maceration, or loss of Negative Pressure Wound Therapy (NPWT). The
frequency should be determined by the clinician based on individual characteristics of the patient and wound.
NPWT devices are not designed to detect or issue an alarm condition based on the presence of bleeding or
pooling. These conditions may only be detected by frequent monitoring.
Special attention to the risks of bleeding or loss of NPWT should be considered when prescribing for use in
the Home Environment.
Page 1 of 3
NPWT may be impacted by various conditions related to system configuration, set-up and individual characteristics
of the patient and wound (e.g. exudate characteristics, patient anatomy). Alignment of the port to the opening in
the drape, use of a bridging technique and choice of dressing configuration based on wound characteristics may
impact NPWT vacuum delivery over the course of therapy. Exudate volume, viscosity and consistency may
influence fluid removal or occlusion formation. A full canister, incorrect canister orientation and device/tubing
height relative to the wound can contribute to loss of NPWT and exudate accumulation within the wound, which
could lead to maceration, infection, or unrecognised bleeding.
Monitor the wound for infection and ensure that all wound filler is removed at each dressing change to reduce the
risk of infection.
Skin grafts should be closely monitored to ensure NPWT is being delivered.
The revised User Manuals / IFU will also include the following “Cautions” for blockage alarms and leak alarms:
Caution – Lack of Blockage alarm:
If partial blockage occurs, the change in pressure status detected by device may not be significant enough to
trigger alarm activation. Over time if blockage reaches point of full occlusion, complete blockage alarm will activate.
Blockage formation within the wound dressing will not be detected by the system as it has occurred outside of the
monitored vacuum circuit, but can affect pressure status at the wound. Appropriately frequent monitoring of wound
dressing is recommended to confirm adequate delivery of therapy.
In the event of heavy or viscous drainage, drainage with sediment or when blood is present, regular monitoring and
more frequent dressing changes may be required.
If a complete blockage is present in the system, but an air leak occurs between blockage and device, the alarm
may not activate. Ensure all connections are secure and no air leaks are present in system.
Potential sources of air leaks include:

Misplaced or worn O-ring on the RENASYS GO device inlet port, located between the device and canister

Partially inserted in-line bacterial overflow guard on the RENASYS EZ/EZ PLUS/EZ MAX devices

Tear in Soft Port


Misplaced or worn O-ring within the quick click connector (between the Soft Port and canister tubing)
Cracked or damaged canister
Caution – Lack of Leak alarm:
Under specific circumstances, a significant air leak may occur in system without device activating a high flow/leak
alarm. This may be due to partial blockage between source of air leak and device, prohibiting detection of the leak
by device, resulting in no alarm activation.
Potential sources of blockage include:



Physical occlusion in wound dressing (coagulated blood or purulent material in filler, compacted filler, high
volume viscous fluid)
Physical occlusion in tubing (kink in canister tubing, clot in tubing)
Soft Port aperture misaligned to dressing opening.
Check wound dressing regularly to ensure it is fully compressed and firm to the touch. Page 2 of 3
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
300ml
200ml
100ml
50ml
Clinician User Manual
REF 66800164
only
w
EN
Clinician User Manual
only
Table of contents
Introduction4
Starting therapy
13
Device description
4
Pause/adjust therapy
14
Features and functions
4
Lock or unlock the keypad
14
Important information
Monitoring NPWT
Turn off the device
14
7
Modes of operation
14
Indications for use
7
Clinician information – therapy time
15
Clinician information – total time
15
Clinician information – battery charge
15
Battery power
16
Troubleshooting guide
18
Contraindications7
Warnings 7
Precautions8
Physician orders
9
Glossary of symbols
10
Dressing changes
11
Canister selection
11
Installing canister
12
Removing or changing canister
12
Connect RENASYS Soft Port
dressing and canister
12
Accessories25
Maintenance27
Device replaceable components
27
Storage27
Returning device
27
Electromagnetic compatibility 28
Specifications29
Disconnect RENASYS Soft Port
dressing and canister
12
Caution statements
30
Device start up
13
Limited warranty 31
Software version
13
Global customer assistance
Language selection
13
xxx
EN
Introduction
The RENASYS GO runs on AC mains power with an AC
power adaptor or internal battery power. The internal
battery charges when the device is plugged into AC
mains power both during operation and when turned
off and not in use.
This user manual contains important information
regarding the safe and effective operation of the
RENASYS™ GO Negative Pressure Wound Therapy
(NPWT) system. This device (REF 66800164) is intended
for use by or on the direction of a trained and licensed
physician. This manual is intended to aid in the training
of personnel and to provide a reference for experienced
users.
The RENASYS GO should be positioned no more than
19in or 50cm higher than the wound and face user's/
operator's location.
For proper and effective use of the RENASYS GO
device, use only with RENASYS GO canisters, RENASYS
dressing kits and RENASYS ancillary componentry.
Refer to instructions for use provided with dressing
kits for additional information on dressing use and
maintenance.
Device description
The RENASYS GO suction device is designed to
provide Negative Pressure Wound Therapy to a closed
environment over a wound, in order to evacuate
exudates from the wound site to a disposable
container, which may promote wound healing via
removal of fluids, including irrigation and body fluids,
wound exudates and infectious materials.
The RENASYS GO is a portable Negative Pressure
Wound Therapy (NPWT) device. It is designed to be
used with Smith & Nephew power supply
(REF 66800161).
The closed environment is created by applying a
RENASYS sterile wound dressing to the wound site and
connecting the sealed wound to the suction device.
Features and functions
User interface
Status/alarm indicator
Power button
Display screen
Battery status indicator
Start/pause therapy
and select
Up and down selectors
Keypad lock
O-ring
Inlet port
4
Audio pause
EN
Canisters • 300ml and 750ml
(300ml canister shown here)
Canister clips
300ml
200ml
Viewing window
100ml
50ml
Tethered connector caps
Canister Tube
Quick click
connector
!
50ml
100ml
200ml
300ml
5
EN
Proper use/correct orientation
Incorrect orientation
X X
*smith&nephew
GO
RENASYS™
Pressure Wound
Negative
Therapy
Negative Pressure
Therapy
ephew
*smith&n ™GO
RENASYS
Wound
✓
Negative
Therapy
*smith&nephew
O
RENASYS™G
Pressure Wound
RENASYS™ GO device may also be used in a horizontal
orientation, with device facing upward.
Negative
Therapy
ew
*smith&nephS™GO
RENASYPressure Wound
However, to maximize canister volume and optimize
canister over-capacity alarm, upright device orientation
is recommended.
Caution: When device is operating in horizontal
orientation, facing upward, alarm functionality may be
compromised. Monitor wound dressing to ensure it is
fully compressed and firm to the touch.
Power inlet and power supply
ephew
*smith&n O
RENASYS™G
Pressure Wound
Negative
Therapy
AC mains power inlet
Power supply with DC cord
6
EN
Important information
Monitoring NPWT
Contraindications
Use of RENASYS GO is contraindicated in the presence
of:
• Untreated osteomyelitis
• Exposed arteries, veins, organs or nerves
• Necrotic tissue with eschar present
• Malignancy in wound (with exception of palliative
care to enhance quality of life)
• Non-enteric and unexplored fistulas
• Anastomotic sites
Carefully monitor the patient, device, and dressing
frequently to determine if there are any signs of
bleeding, exudate accumulation (pooling), infection,
maceration, or loss of Negative Pressure Wound
Therapy (NPWT). The frequency should be determined
by the clinician based on individual characteristics of
the patient and wound. NPWT devices are not designed
to detect or issue an alarm condition based on the
presence of bleeding or pooling. These conditions may
only be detected by frequent monitoring.
Warnings
Special attention to the risks of bleeding or loss of
NPWT should be considered when prescribing for
use in the Home Environment.
1. Carefully monitor patients for signs of bleeding,
which may lead to interruption in therapy and
hemodynamic instability. If such symptoms are
observed, immediately discontinue therapy, take
appropriate measures to control bleeding, and
contact treating clinician.
NPWT may be impacted by various conditions
related to system configuration, set-up and individual
characteristics of the patient and wound (e.g. exudate
characteristics, patient anatomy). Alignment of the
port to the opening in the drape, use of a bridging
technique and choice of dressing configuration based
on wound characteristics may impact NPWT vacuum
delivery over the course of therapy. Exudate volume,
viscosity and consistency may influence fluid removal
or occlusion formation. A full canister, incorrect canister
orientation and device/tubing height relative to the
wound can contribute to loss of NPWT and exudate
accumulation within the wound, which could lead to
maceration, infection, or unrecognized bleeding.
2. Patients suffering from difficult hemostasis or
who are receiving anticoagulant therapy have an
increased risk of bleeding. During therapy, avoid
using hemostatic products that, if disrupted, may
increase the risk of bleeding.
3. Do not use directly on exposed blood vessels or
organs. Sharp edges such as bone fragments must
be covered or removed prior to initiating therapy,
due to risk of puncturing organs or blood vessels
drawn closer under the action of negative pressure.
Monitor the wound for infection and ensure that all
wound filler is removed at each dressing change to
reduce the risk of infection.
4. NPWT has not been studied on pediatric patients.
Patient size and weight should be considered
when prescribing the device.
Skin grafts should be closely monitored to ensure
NPWT is being delivered.
5. Foam or gauze must not be tightly packed or forced
into any wound area. Over-packing may interfere
with distribution of NPWT evenly across the wound.
This may decrease the ability of the wound to
properly contract and permit exudate to remain in
wound.
Review Contraindications, Warnings & Precautions
before use.
Indications for use
6. In the event defibrillation is required, disconnect
device from wound dressing prior to defibrillation.
Remove wound dressing only if its location will
interfere with defibrillation.
RENASYS™ GO is indicated for patients who would
benefit from a suction device (Negative Pressure
Wound Therapy), as it may promote wound healing via
removal of fluids, including irrigation and body fluids,
wound exudates and infectious materials.
7. Device is not MRI compatible. Do not bring
device into MRI suite. Prior to entering MRI suite,
disconnect device from dressing. Dressing can
remain intact on patient.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps and grafts
8. Device is unsuitable for use in areas where there is
danger of explosion (e.g., hyperbaric oxygen unit).
7
EN
9. When operating, transporting or disposing of
device and accessories, there is risk of infectious
liquids being aspirated or contamination of
device assembly through incorrect use. Universal
precautions should be observed whenever working
with potentially contaminated components or
equipment.
7. In the event a patient with spinal cord injury
experiences autonomic dysreflexia, discontinue
use of NPWT and immediately seek medical
assistance.
8. When treating enteric fistulas, do not place NPWT
dressing in direct contact with exposed bowel.
Cover the wound bed, including fistula opening,
with non-adherent gauze or with one layer of saline
moistened gauze. During the course of treatment
patient’s fluid levels must be closely monitored.
10. Device and canister kits are provided non-sterile
and should not be placed within a sterile field.
Precautions
9. Avoid use of circumferential dressings except in
cases of oedema or heavily exuding extremities,
where this technique may be necessary to
maintain a seal. Consider using multiple drapes
to minimize risk of decreased distal circulation.
Regularly assess distal pulses, and discontinue
therapy if changes in circulation are detected
1. More frequent device and wound dressing
monitoring, should be taken for patients who are
or may be:
• Suffering from infected blood vessels
• Receiving anticoagulant therapy or platelet
aggregation inhibitors, in addition to patients
with intrinsic coagulation problems such as low
platelet counts
• Actively bleeding or have friable blood vessels
or organs
• Suffering from difficult wound hemostasis
• Untreated for malnutrition
• Noncompliant or combative
• Suffering from wounds in close proximity to
blood vessels or delicate fascia
10. Monitor patient for any signs of local or systemic
infection. Infected wounds may require more
frequent dressing changes. As NPWT is not
intended to directly treat infection, if there are any
signs of systemic infection or advancing infection at
wound area, contact treating clinician immediately.
11. If multiple pieces of foam or gauze are needed
to fill the wound profile, count and record how
many pieces are present to ensure all pieces are
removed at a dressing change to minimize the risk
of retention and possible infection.
When monitoring patients for delivery of therapy,
ensure wound dressing is free of air leaks, fully
compressed and firm to the touch.
12. NPWT should remain on for duration of treatment.
The length of time a patient may be disconnected
from device is a clinical decision based on individual
characteristics of patient and wound. Factors to
consider include location of wound, volume of
drainage, integrity of dressing seal, assessment of
bacterial burden and patient’s risk of infection.
2. As a condition of use, device should only be used
by qualified and authorized personnel. User must
have necessary knowledge of the specific medical
application for which NPWT is being used.
3. For patients with high risk of bleeding use 300ml
canister. Ensure the 300ml canister viewing is
checked frequently for signs of bleeding.
13. Do not use a dressing kit with breached or
damaged packaging.
14. Use of NPWT presents a risk of tissue in-growth.
Tissue in-growth may be reduced by reducing
therapy pressure, using a wound contact layer or
increasing the frequency of dressing changes.
4. In the event of heavy or viscous drainage, drainage
with sediment or when blood is present, regular
monitoring and more frequent dressing changes
may be required to reduce the risk of interruption
of therapy, maceration, infection, and ensure
proper exudate removal.
15. NPWT should not be painful. If patient reports
discomfort, consider reducing pressure setting and
use of a wound contact layer. Pressure setting is a
clinical decision based on individual characteristics
of patient and wound. Factors to consider include
location of wound, volume of drainage and integrity
of dressing seal.
5. Underlying structures, such as bone, tendons,
ligaments and nerves should be covered with
natural tissue or a non-adherent dressing layer
prior to applying the NPWT dressing to ensure
protection and minimize the risk of damage from
direct contact with the dressing.
16. Maintain regular monitoring of device and wound
site during therapy to ensure therapeutic treatment
and patient comfort.
6. To minimize the risk of bradycardia, do not place
NPWT in proximity to the vagus nerve.
8
EN
17. Device is only to be used with Smith & Nephew
authorized components. Use of any other products
have not been proven safe and effective with
RENASYS™ GO device.
28.As with all adhesive products, apply and remove
dressing carefully from sensitive or fragile skin to
avoid blistering and skin stripping, especially after
frequent dressing changes. Use of skin sealant
may assist with protection of periwound skin.
18. Ensure canister tubing and RENASYS Soft Port
are installed completely and without any kinks to
avoid leaks or blockages in vacuum circuit. Position
device and tubing appropriately to avoid risk of a
trip hazard. Device and system tubing should be
positioned no more than 19 inches or 50cm higher
than the wound to ensure optimization of therapy
and prevent therapy interruption.
29.If patient must be disconnected, the ends of the
RENASYS Soft Port and canister tubing should be
protected using tethered caps to avoid leakage of
fluid and cross contamination.
Physician orders
Prior to placement of RENASYS GO, the medical
professional treating the wound must assess how
to best use the system for an individual wound. It is
important to carefully assess wound and patient to
ensure clinical indications for Negative Pressure Wound
Therapy (NPWT) are met.
19. When bathing or showering patient must
disconnect from device, protecting both ends of
RENASYS Soft Port tubing using tethered caps.
Ensure aeration disc located near quick click
connector is free of moisture before reactivation of
therapy to ensure proper alarm functionality and
prevent interruption in therapy.
All orders should include:
• Wound location, size and type
• Smith & Nephew wound dressing kit
• Pressure settings
• Frequency of dressing changes
• Adjunctive dressings
20.If any liquids penetrate device, discontinue use and
return to your Smith & Nephew authorized provider
for service.
21. CT scans and x-ray have the potential to interfere
with some electronic medical devices. Keep device
out of x-ray or scanner range.
22.Use caution if device is used in the presence of
a flammable anesthetic mixture with air or with
oxygen or nitrous oxide.
23.AC mains power can only be removed by
disconnecting power cord or AC power adaptor.
Take care in positioning the device to allow access
to cord receptacle.
24.If power cord is damaged, wires are frayed or
exposed, do not use power cord. Contact your
Smith & Nephew representative for a replacement
cord.
25.Canisters should be changed at least once a
week, whenever there is a change in patient or in
the event that canister contents reach maximum
volume indication (300ml or 750ml fill line).
Do not wait for the canister over-capacity alarm
to activate to change canister.
26.Canisters kits are single use devices. Do not reuse.
27. Do not apply SECURA™ No-sting barrier film wipes
directly to open wounds. SECURA No-sting barrier
film is flammable. Use in a well ventilated area.
Avoid using around flames and sources of ignition
Keep out of reach of children. For external use only.
9
EN
Glossary of symbols
Keypad lock
Locks keypad to restrict accidental
adjustment of therapy. When activated,
the light will illuminate solid blue.
Power
Turns device ON and OFF.
Battery indication
Shows status of device battery life.
Audio pause
Pauses alarm for approximately
2-3 minutes. When activated the light
will illuminate and flash yellow.
Up selector
Allows pressure setting to be increased
and scroll through menu options.
If a new alarm occurs, the audio pause
will cancel. (This feature available with
software version 0.66 and later).
Down selector
Allows pressure setting to be decreased
and scroll through menu options.
Start/pause therapy and select
Starts or pauses therapy. It is also used to
confirm settings within therapy.
Equipment
Classification
Isolation type BF applied
part
Single Use
Do not reuse
European
Representative
CSA International
Classification
Keep Dry
Lot Number
EU:
Not for general waste
Storage Temperature
Serial Number
Refer to instruction
manual/booklet
Date of Manufacture
Product Catalogue
Number
Caution:
Follow instructions for
use
Manufacturer
CE Mark
Do not use if package is
damaged
MR
MRI Unsafe
10
only
Caution: U.S. Federal
law restricts this device
to sale by or on the
order of a physician
EN
Dressing changes
Canister selection
Refer to instructions for use provided with dressing
kits for additional information on dressing use and
maintenance.
Device is to be used with RENASYS™ GO 300ml or
750ml canisters.
RENASYS GO canisters use an integral two stage
bacterial filter for protection of device against overflow
and spread of aspirated micro-organisms.
1. Foam dressings should be changed every 48 to
72 hours after the initial application of therapy. If
no leak is present and the patient is comfortable,
subsequent dressing changes should occur no
less than 3 times per week.
Canisters are designed for single patient use.
Do not re-use.
Canisters are provided non-sterile and should not be
used in a sterile field.
2. Gauze dressings should be changed 48 hours
after the initial application of therapy. If no leak is
present and the patient is comfortable, subsequent
dressing changes should occur 2–3 times per
week.
Canisters should be changed at least once a week,
whenever there is a change in patient or in the
event the canister contents reach maximum volume
indication (300ml or 750ml fill line). Do not wait for
alarm activation to change canister.
3. In the event of heavy or viscous drainage, drainage
with sediment or when blood is present, regular
monitoring and more frequent dressing changes
may be required.
Canisters may have to be changed regularly within
single-patient treatment episodes if exudate levels
are high. Check canisters regularly to monitor exudate
levels, ensuring they are below maximum volume
indication (300ml or 750ml fill line).
4. When dressing a wound involving a difficult to seal
anatomy or exposure to external moisture, frequent
inspection of dressing is recommended to ensure a
seal is maintained. Ensure wound dressing is fully
compressed and firm to the touch.
Check canister for any signs of cracks or damage. If
noted, discard and replace canister.
Ensure canister viewing window is checked frequently
for signs of bleeding.
5. Ensure all wound filler material placed in the
wound has been removed before redressing the
wound. If foam dressing adheres to the wound,
apply saline into the wound dressing and let it
set for 15–30 minutes before gently removing the
foam. Appropriately discard used wound dressings
observing your institution’s protocol for medical
waste handling.
For patients with high risk of bleeding, use 300ml
canister.
6. As with all adhesive products, apply and remove
dressing carefully from sensitive or fragile skin
to avoid skin stripping, especially after frequent
dressing changes. Use of skin sealant may assist
with protection of periwound skin.
7. Monitor patient for any signs of local or systemic
infection by checking dressing frequently. Infected
wounds may require more frequent dressing
changes. As NPWT is not intended to directly
treat infection, if there are any signs of systemic
infection or advancing infection at wound area,
contact treating clinician immediately.
11
EN
Installing canister
Connect RENASYS™ Soft Port dressing
and canister
1. Ensure device is off.
Connect Soft Port to canister tubing by pushing orange
quick click connectors together. An audible click
indicates connection is secure.
2. Remove paper tape around canister tubing to
release tubing to full length.
3. Open both orange clips on sides of canister.
4. Align canister so that viewing window is facing
forward.
5. Push canister gently over device inlet port.
6. Engage both canister clips. Clips will click when
properly engaged.
7. Following canister installation, to verify functional
complete blockage alarm, turn device on and insert
tethered cap of canister tubing into connector
to simulate a blockage. A functional device will
activate a complete blockage alarm within 5
minutes.
In the case that complete blockage alarm does not
activate, check canister installation and contact
your Smith & Nephew authorized representative.
Note: Do not cover aeration disc.
Disconnect RENASYS Soft Port dressing
and canister
1. Hold orange quick click connector above wound to
help ensure exudate does not leak from tubing.
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
*smith&nephew
RENASYS™ GO
2. Turn device off.
Negative Pressure Wound
Therapy
3. Disconnect canister tubing from Soft Port.
300ml
300ml
300ml
200ml
100ml
200ml
100ml
200ml
100ml
50ml
50ml
50ml
Removing or changing canister
1. Hold orange quick click connector above wound to
help ensure exudate does not leak from tubing.
2. Turn device off.
3. Disconnect canister tubing from Soft Port.
4. Insert tethered cap into both sides of orange quick
click connector.
5. Release orange canister clips on sides of canister
and gently pull away from device.
4. Insert tethered cap into both sides of orange quick
click connector.
Disposal of used canisters should follow
facility protocols or local ordinances
relating to handling of potentially
infected or biohazardous materials.
12
EN
Device start up
Language selection
Device operates on both battery and AC mains power.
To change language selection:
If battery operation is required for first use of device,
battery must be charged from AC mains power until
battery status top indicator light illuminates solid green.
During charging process the battery status top indicator
light will flash green.
1. Turn device off.
2. Simultaneously press and hold
Up
To activate device, press and hold Power
for 2 seconds. Device display will show:
W e l c o m e
S t a r t i n g
+ Power
buttons for 2
3. Language can now be selected using
button
Up
and Down
buttons to scroll to desired
language, followed by Select
V X . X X
4. Pressing Select
button.
button at this point will power
on the device at a preset 80mmHg in continuous
mode, if the device is being used for the first time,
or the previously entered pressure setting.
S t a n d b y
► 1 0 0
mmH g
If device is being used for the first time, the user will be
given the option to select desired language:
Starting therapy
►E n g l i s h
D a n s k
1. Select prescribed pressure setting using
Up
Software version
and Down
2. Press Select
To access software version of a device:
buttons.
button to start therapy.
C o n t i n u o u s
► 1 0 0
mmH g
1. Turn device off.
2. Press and hold Power
3. Finished dressings should be fully compressed,
button for 2 seconds.
firm to the touch and leak free.
Device display will show:
W e l c o m e
S t a r t i n g
+ Select
seconds.
If AC mains power is required, connect power supply to
the AC mains power inlet, on the side of device.
Setting pressure level is a decision that the healthcare
provider must make based on an individual
assessment of the particular wound.
V X . X X
3. The software version is provided on the lower right-
40-120mmHg is recommended therapeutic pressure
range.
hand corner of the welcome display screen.
In the event you have a wound that is difficult to seal,
you may increase the pressure setting to achieve
desired negative pressure at the wound bed.
Device will show set pressure level. If device detects
operation outside of the set pressure, it will result in
alarm activation.
Caution: Before starting therapy ensure that device
and system tubing are located no more than 19in or
50cm higher than the wound and is away from any
direct sources of heat.
13
EN
Pause/adjust therapy
Modes of Operation
RENASYS™ GO offers both continuous and intermittent
modes. Selection of therapy mode setting is a clinical
decision based on physician judgment, wound type,
exudate level, exudate consistency and patient
comfort.
Therapy may be paused by pressing
Select
button once. When paused, device will
show a standby message on display screen and
pressure setting can be changed using Up
Down
and
In continuous mode, device will maintain selected
pressure setting without stopping until switched off.
buttons.
In intermittent mode, device cycles on and off
in increments of 5 minutes “ON” (active vacuum) and
2 minutes “OFF” (no vacuum).
S t a n d b y
► 1 0 0
mmH g
Press Select
Intermittent therapy is not recommended for:
button to restart therapy.
• Highly exudating wounds
Lock or unlock keypad
• Wounds with tunnels or undermining
To lock user interface when device is active, press and
• Wounds in difficult areas where maintaining a seal
is problematic
hold Keypad Lock
button for 2 seconds. When
• Patients who experience pain during intermittent
therapy
activated, the light will illuminate solid blue.
To change therapy between continuous and
intermittent mode:
K e y p a d
L o c k e d
► 1 0 0
mmH g
If keypad on user interface has not been used for 15
minutes, keypad will automatically lock.
1. Turn device off.
In active mode, if keypad on user interface has not
been used for 15 minutes, keypad will automatically
lock. The light above keypad lock button will illuminate
solid blue.
2. Simultaneously press and hold
(This feature is available with software version 0.66 and
later).
3. Use Up
Down
or Down
Press the Select
button for 2 seconds.
buttons for
buttons to scroll
button to confirm.
Once therapy is started, display screen will show which
mode of therapy has been selected.
K e y p a d
A c t i v e
► 1 0 0
mmH g
Note: Locking keypad only locks row of keys under
display screen — Power Button is not locked.
Turn off the device
Press and hold Power
+ Power
between continuous and intermittent mode.
To unlock user interface, press and hold
Keypad Lock
+ Select
2 seconds.
button for 2 seconds to
power off device.
14
EN
Clinician information — therapy time
Clinician information — total time
Device displays information which allows clinicians to
see therapy time (total hours and minutes of continuous
or intermittent therapy) delivered to the patient.
This feature is available with software version 0.66 and
later.
Device displays total number of hours accumulated in
active mode. This time cannot be reset.
To access therapy time:
To access total time display screen:
1. Turn device off.
1. Turn device off.
2. Simultaneously press and hold
Down
+ Select
+ Power
buttons for
2. Simultaneously press and hold
2 seconds.
Down
3. Use Down
to show the following
3. Press Down
display screen:
T o t a l
x x x x x
then return to main menu.
main menu.
Clinician information — battery charge
button to scroll to "clear time"
option. Press Select
This feature is available with software version 0.66 and
later.
button to show the
following display screen:
Device displays percentage of battery charge
remaining.
A c t i v e
2. Press Select
To access battery charge display screen:
button again to confirm that you
1. Turn device off.
want to clear active time.
3. Use Down
Press Select
T i m e
H
4. Display will show for 5 seconds and then return to
To reset therapy time:
C l e a r
►T i m e ?
to show the following
display screen:
m
4. Therapy time display will show for 5 seconds and
1. Use Down
buttons for
button to scroll to "total time"
option. Press Select
A c t i v e
T i m e
x x x x x
H ,
x x
+ Power
2 seconds.
button to scroll to "show time"
option. Press Select
+ Select
2. Simultaneously press and hold
Down
button to scroll to "yes" option.
+ Select
+ Power
buttons for
2 seconds.
button to show the following
3. Press Down
display screen:
button to scroll to "battery charge"
option. Press Select
A c t i v e
T i m e
C l e a r e d
to show the following
display screen:
4. Display will show for 5 seconds and then return to
B a t t e r y
x x x %
main menu.
4. Press Select
Active time should be cleared between patients.
This will allow the clinician to monitor patient
therapy compliance.
menu.
15
C h a r g e
button to return to the main
EN
Battery power
Device can be used on battery power to allow greater user mobility. A fully charged battery will last up to
20 hours.
During therapy, if battery level is low, the device can be plugged into AC mains power without interrupting therapy.
Battery will recharge while therapy continues to be delivered.
Battery status indication
RENASYS™ GO contains a lithium ion rechargeable battery. There are several battery level indicators on RENASYS GO
device:
Indicator
B a t t e r y
F u l l
► 1 0 0
mmH g
Battery level
Action
Battery is fully charged and has up to
20 hours active therapy remaining.
Battery status top indicator will
illuminate solid green.
No action required.
Battery has up to 10 hours active
therapy remaining.
Battery status top indicator will flash
green.
No action required.
Battery has up to 6 hours active therapy No action required.
remaining.
Battery status top indicator will flash
green and battery status bottom
indicator will illuminate solid amber.
A t t e n t i o n
L o w
B a t t e r y
Battery has up to 3 hours active therapy
remaining.
Battery status bottom indicator will
illuminate solid amber.
Audible alarm will beep 2 times every
30 seconds.
Audio alarm can be paused
by pressing the audio pause
button on user interface.
Plug device into AC mains
power to charge battery.
R E C H A R G E
V . L o w
B a t t e r y
Battery has up to 1 hour active therapy
remaining.
Battery status bottom indicator will flash
amber.
Audible alarm will beep 3 times every
10 seconds.
Device should be plugged
into AC mains power to
charge battery and ensure
continued delivery of
therapy.
! !
R E C H A R G E
! ! E X . L OW
B A T T E R Y
Battery has only 2 minutes of active
therapy remaining.
Battery status bottom indicator will flash
amber.
Audible alarm will sound continuously
for 2 minutes.
Device should be plugged
into AC mains power or
therapy will discontinue.
!
!
! !
! !
16
EN
Indicator
! !
! !
R E C H A R G E
N OW !
B A T T E R Y
F A I L
C h a r g i n g
►1 0 0
mmH g
! B A T T E R Y
F A I L E D
►1 0 0
mmH g
This feature is available with software
version 0.66 and later.
Battery level
Action
After 2 minutes in an extremely low
battery charge state, device will power
off.
Plug device into AC mains
power.
When plugged into AC mains power
display screen will show “Charging”
message and battery status top
indicator will flash green.
No action required. Device
may take up to
3 hours to charge.
If battery unit within device has failed
to charge, display screen will show
“Battery Failed” message and battery
status bottom indicator will flash amber.
Therapy will only be
delivered if plugged into AC
mains power. Device will not
operate on battery power.
Note: This will only display when
connected to AC mains power.
Contact your
Smith & Nephew authorized
representative.
Caution: Keep device away from direct heat sources during charging.
17
EN
Troubleshooting Guide
Alarm status with display screen
Cause
Remedy
Low Vacuum Alarm
! !
! !
WA R N I N G
L OW
V A C U U M
Vacuum level is lower than NPWT
set point by >15mmHg.
• Audible alarm will beep 3
times every 10 seconds.
• Status/alarm indicator light will
flash amber.
Device is unable to
achieve selected vacuum
level due to internal
device malfunction or
a significant leak in the
system.
• Secure engagement of canister to
device
3. Disconnect Soft Port from canister tubing
at orange quick click connector and insert
tethered cap into both connectors.
A U D I O
P A U S E D
L OW
V A C U U M
• Pressing audio pause button
will pause audible alarm for
approximately 2-3 minutes.
! !
! !
2. Ensure the following connections are
secure:
• Orange quick click connector between
Soft Port and canister tubing
• Once corrected, alarm will
automatically reset and status/
alarm indicator will return to
solid green.
! !
! !
1. With device actively creating vacuum, check
wound dressing for air leaks. Look for loose
or decompressed dressing appearance,
listen for air movement around dressing
and feel for areas less compressed or
cooler in temperature. Address identified
leaks with transparent film or adhesive gel
patch.
• If alarm condition continues, there is
a potential issue with the device or
canister. Replace canister and contact
your Smith & Nephew authorized
representative.
T H E R A P Y
S T O P
L OW
V A C U U M
• Device will stop delivering
therapy after pausing alarm
5 times, without addressing
condition.
• If alarm condition resolves, an air leak
is present within the wound dressing
or Soft Port. Reassess and replace as
needed.
Note: If low vacuum alarm is due to a leak
in system, the high flow/leak alarm may also
activate while low vacuum alarm is active.
Note: If over vacuum alarm indicator is
illuminated along with low vacuum indicator,
follow troubleshooting steps for over vacuum
alarm.
18
EN
Alarm status with display screen
Cause
Remedy
Device has detected a
high vacuum condition
potentially due to line
blockage or device
malfunction.
1. Inspect connections and tubing to ensure
they are free of obstructions. Ensure there
are no kinks in canister tubing.
Device has reached
high vacuum level
(>235mmHg).
1. Press and hold power button for 2 seconds
to turn device OFF.
High vacuum alarm
! !
! !
WA R N I N G
H I G H
V A C U U M
Vacuum level is higher than NPWT
set point by >15mmHg for more
than 30 seconds.
• Audible alarm will beep 3
times every 10 seconds.
• Status/alarm indicator will
flash amber.
• This audio alarm cannot
be paused and must be
investigated by healthcare
provider immediately and
corrected.
2. Replace canister.
3. If alarm condition continues, device may
have malfunctioned. Contact your
Smith & Nephew authorized
representative.
• Once corrected, alarm will
automatically reset and status/
alarm indicator will return to
solid green.
Over vacuum alarm
! !
! !
T H E R A P Y
S T O P
O V E R
V A C U U M
! !
T H E R A P Y
S T O P
! ! R e s t a r t
D e v i c e
The system has encountered
an excessively high vacuum (of
>235mmHg).
• Vacuum safety switch will
operate and device will stop
delivering therapy.
2. Inspect connections and tubing to ensure
they are free of obstructions. Ensure there
are no kinks in canister tubing.
3. Replace canister.
• Audible alarm will beep 3
times every 10 seconds.
4. Turn device back ON by pressing and
holding power button for 2 seconds. If
alarm condition continues, device may
have malfunctioned. Contact your
Smith & Nephew authorized
representative.
• Status/alarm indicator will
flash amber.
• This audio alarm cannot
be paused and must be
investigated by healthcare
provider immediately and
corrected.
19
EN
Alarm status with display screen
Cause
Remedy
Complete blockage/canister
over-capacity
! !
! !
1. Check canister. If contents have reached
maximum volume indication (300ml or
750ml fill line), replace canister.
WA R N I N G
B L O C K A G E / F U L L
Device detects a complete
blockage in vacuum circuit. There
is no negative pressure at wound
site.
• Audible alarm will beep 3
times every 10 seconds.
• Status/alarm indicator will
flash amber.
There is a complete
blockage in system; this
includes a canister where
contents have exceeded
maximum volume
capacity or in the instance
that the internal canister
filter is covered with
exudate.
• Once corrected, alarm will
automatically reset and the
status/alarm indicator will
return to solid green.
! !
! !
3. Disconnect Soft Port from canister tubing
at orange quick click connector. Insert
tethered cap into Soft Port connector. Allow
air to flow freely into canister.
• If alarm condition continues, there is
a potential issue with the device or
canister. Replace canister and contact
your Smith & Nephew authorized
representative.
• If alarm condition resolves, a blockage
is present within the Soft Port.
Reassess and replace as needed.
A U D I O
P A U S E D
B L O C K A G E / F U L L
• Pressing audio pause button
will pause audible alarm for
approximately 2-3 minutes.
! !
! !
2. Inspect connections, tubing and Soft Port
aeration disc (located on Soft Port, near
the orange quick click connector) to ensure
they are free of obstructions. Ensure there
are no kinks in canister tubing.
Caution: Do not wait for alarm activation to
change canister. At point of alarm activation,
canister contents have exceeded maximum
volume capacity, potentially impacting device
alarm functionality.
T H E R A P Y
S T O P
B L O C K A G E / F U L L
• The device will stop delivering
therapy after pausing alarm
5 times, without addressing
condition.
Note: Device and canister should be kept in an
upright orientation to optimize canister overcapacity alarm functionality while maximizing
canister volume.
20
EN
Alarm status with display screen
Cause
Remedy
Caution – Lack of alarms:
If partial blockage occurs, the change in
pressure status detected by device may
not be significant enough to trigger alarm
activation. Over time if blockage reaches point
of full occlusion, complete blockage alarm will
activate.
Blockage formation within wound dressing
will not be detected by system as it has
occurred outside of monitored vacuum circuit,
but can affect pressure status at the wound.
Appropriately frequent monitoring of wound
dressing is recommended to confirm adequate
delivery of therapy.
In the event of heavy or viscous drainage,
drainage with sediment or when blood is
present, regular monitoring and more frequent
dressing changes may be required.
If a complete blockage is present in the system,
but an air leak occurs between blockage and
device, the alarm may not activate. Ensure all
connections are secure and no air leaks are
present in system. Potential sources of air leaks
include:
• Misplaced or worn O-ring on the device
inlet port, located between the device and
canister
• Tear in Soft Port
• Misplaced or worn O-ring within the quick
click connector (between the Soft Port and
canister tubing)
• Cracked or damaged canister
21
EN
Alarm status with display screen
Cause
Remedy
High flow/leak alarm
! !
! !
WA R N I N G
L E A K
Device detects a significant leak in
the system.
• Alarm will beep 3 times every
10 seconds.
• Status/alarm indicator will
flash amber.
• Once corrected, alarm will
automatically reset and status/
alarm indicator will return to
solid green.
! !
! !
A U D I O
L E A K
There is a significant
leak in the system. This
could include an air leak
around the dressing or
a poor seal at one of
the connectors between
the dressing, Soft Port,
canister or device.
1. With device actively creating vacuum, check
wound dressing for air leaks. Look for loose
or decompressed dressing appearance,
listen for air movement around dressing
and feel for areas less compressed or
cooler in temperature. Address identified
leaks with transparent film or adhesive gel
patch.
2. Ensure the following connections are
secure:
• Orange quick click connector between
Soft Port and canister tubing
• Secure engagement of canister to
device
3. Disconnect Soft Port from canister tubing
at orange quick click connector and insert
tethered cap into both connectors.
P A U S E D
• Pressing audio pause button
will pause audible alarm for
approximately 2–3 minutes.
• If alarm condition continues, there is
a potential issue with the device or
canister. Replace canister and contact
your Smith & Nephew authorized
representative.
• If alarm condition resolves, an air leak
is present within the wound dressing
or Soft Port. Reassess and replace as
needed.
Note: An air leak may result in a pressure drop
occurring within the system. As a result, the
low vacuum alarm may also activate while the
high flow/leak alarm is active.
22
EN
Alarm status with display screen
Cause
Remedy
Caution – Lack of alarms: Under specific
circumstances, a significant air leak may
occur in system without device activating
a high flow/leak alarm. This may be due to
partial blockage between source of air leak
and device, prohibiting detection of the leak
by device. As a result, alarm will not activate.
Over time, if blockage reaches point of full
occlusion, the complete blockage alarm will
activate. Read complete blockage/canister
over-capacity alarm troubleshooting for
instruction on locating the system blockage.
Check wound dressing regularly to ensure it is
fully compressed and firm to the touch.
Inactive alarm
This feature is available with
software version 0.66 and later.
!
!
A t t e n t i o n
I N A C T I V E
Device has been left in standby
mode for longer than 15 minutes.
• Alarm will beep 2 times every
30 seconds.
• Status/alarm indicator will
flash amber.
!
!
Device has been left in
standby mode without
any keys being pressed
for longer than
15 minutes.
A U D I O
P A U S E D
I N A C T I V E
• Pressing audio pause button
will pause audible alarm for 15
minutes.
• Alarm can only be paused
once.
23
Either select pressure setting and start therapy
or turn device OFF until therapy is required.
EN
Alarm status with display screen
Cause
Remedy
Battery partially
discharged or depleted.
Plug unit into AC mains power to charge
battery.
User interface is locked.
Unlock by pressing and holding keypad lock
button for 2 seconds.
Internal hardware or
software error.
Contact your Smith & Nephew authorized
representative.
Service and repair
required.
Contact your Smith & Nephew authorized
representative.
Internal hardware failure.
Contact your Smith & Nephew authorized
representative.
Battery
See battery status and alarm
section of manual for screen
messages.
Keypad lock on
K e y p a d
L o c k e d
► 1 0 0
mmH g
When lock is active, keypad will
illuminate solid blue.
Device failed alarm
! !
! !
D E V I C E
P l e a s e
F A I L E D
R e t u r n
Device has an unrecoverable error.
• Status/alarm indicator will
flash amber.
Device not calibrated alarm
! !
! !
D E V I C E
N O T
C A L I B R A T E D
Device will not operate.
• Alarm will beep 3 times every
10 seconds.
• Status/alarm indicator will
flash amber.
Battery failed alarm
This feature is available with
software version 0.66 and later.
! ! B A T T E R Y
F A I L E D
► 1 0 0
mmH g
Battery within device has failed.
• Battery status bottom indicator
will flash amber.
• Therapy can only be continued
by keeping device plugged
into AC mains power.
• Status/alarm indicator will
flash amber.
Note: This will only display when
connected to AC mains power.
24
EN
Accessories
Carry straps
To attach carry strap to device:
1. Feed end of open strap behind location pin on side
of device.
2. Pull strap through and feed the end behind clip on carry strap.
3. Close clip to secure strap.
4. Repeat steps 1-3 on other side of device.
Once both sides of the carry straps are connected to device, they can be joined together to make the short carry
strap.
The short carry strap can be used to attach the device to a wheelchair or IV pole when moving patients.
ephew
*smith&n O
RENASYS™G
Pressure Wound
Negative
Therapy
ephew
*smith&n O
RENASYS™G
Pressure Wound
Negative
Therapy
ephew
*smith&n O
RENASYS™G
Pressure Wound
ephew
*smith&n O
RENASYS™G
Pressure Wound
Negative
Therapy
Negative
Therapy
Shoulder and extension straps
The carry strap can be extended to allow the device to be carried on the shoulder or across the body.
Place the padded section of the shoulder strap against shoulder for maximum comfort when carrying device.
Note: Device carry straps are designed for single patient use.
25
EN
Carry bag (available for 300ml canister)
To place the device into the carry bag:
1. Open the zipper on both sides of bag and place face down on a flat surface with viewing flaps on top.
2. Place device face up on the open bottom section of the bag.
3. Pull front of the bag over top of the device and feed both parts of one zipper together.
4. Close zipper on the other side of the bag.
5. Once fitted ensure canister tubing can move freely.
6. Excess tubing can be coiled and placed in the pouch on the back of the carry bag.
Flaps on the front of the bag provide privacy and discretion for the user.
On rear of the bag, there is a belt loop, should the user wish to wear RENASYS™ GO around their waist.
Note: Device carry bag is designed to be a single patient use item.
Negative
Therapy
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*smith&nep
RENASYS™GO
Pressure Wound
*smith&nephew
RENASYS™ GO
Negative Pressure Wound
Therapy
Lifting top flap allows access to
device user interface.
Belt
loop
Belt Loop
Canister
tubing
Tubing Pouchpouch
Lifting bottom flap allows the
canister to be viewed.
Note: Device and canister should remain in an upright orientation to maximize canister volume and optimize
complete blockage/canister over-capacity alarm.
26
EN
Maintenance
2.
Inspect device for visible signs of damage before each
use. If device has been dropped or shows signs of
damage, do not use. Return damaged device to your
Smith & Nephew authorized representative.
Clean the device inlet port and carefully slide new
inlet port O-ring onto device inlet port; checking
that any rolling of the O-ring is corrected once it is
located in the groove of the inlet port.
DO NOT LUBRICATE THE O-RING!
There are no serviceable parts in the device. Do not
attempt to open device housing. Contact your
Smith & Nephew authorized representative or
distributor if service is required.
NOTE: Smith & Nephew does not offer a plastic
removal tool to be used with the RENASYS GO device.
Plastic removal tools may be purchased from vendors
such as Golem Gear (SKU GG_Yellow Pick).
Cleaning
Adherence to facility directives concerning hygiene
is of prime importance. The instructions supplied
with all cleaning agents as well as sterilization and/or
disinfection units must be followed.
Odor filter (REF 66800061)
To minimize unpleasant odors from RENASYS GO
devices, it is recommended that the device odor filter
be replaced between each patient use.
Note: The presence of device odor does not impact
the functionality of the device.
Cleaning of the RENASYS™ GO outer housing should be
done in accordance with the guidelines below:
•
Wipe down device surface with a damp soft cloth.
•
Use a mild cleaning agent, disinfectant, or an
antimicrobial agent and ensure its compatibility
with plastics. Follow manufacturer’s guidelines for
use of cleaning or disinfectant agents.
•
Dampen another soft cloth with clean water and
wipe down all surfaces to remove any excess
solution.
•
Dry with a separate soft cloth.
•
Do not use solvents or abrasives.
•
Do not immerse any part of RENASYS GO in
fluid, directly spray any cleaner onto device or
use a wet cloth that is dripping fluid. No fluids
should be allowed to enter device. If any liquids
penetrate device, contact your local distributor.
To change or verify the presence of the odor
filter, turn the device over and lay it on a soft
surface, to avoid damage.
2.
Remove the Pozidriv® screw holding the rear flap
and open the flap to reveal the odor filter.
3.
Remove the two odor filter elements and replace
with 2 new odor filter elements.
4.
Close the door flap and insert screw, tightening
only until the door flap is flush with the case.
Precaution: TAKE CARE NOT TO OVER-TIGHTEN
SCREW!
Rubber feet (REF 66800611)
If a rubber foot has become detached or is
missing, it may be replaced. Use a small quantity of
cyanoacrylate adhesive to reattach the rubber foot to
the base of the device. Rubber feet can be obtained as
replacement parts.
Device replaceable components
(As performed by appropriately trained
personnel)
Storage
Prior to storage for more than 2 months, ensure that the
battery is fully charged. Some battery discharge may
occur in storage. During long-term storage, recharge
the battery every 10 months.
RENASYS GO replaceable components including
the Inlet O-ring, odor filter and rubber feet may
be purchased through Smith & Nephew. Contact
your Smith & Nephew authorized representative or
distributor for more information.
RENASYS GO should be stored between 0–25°C
(32–77°F) for optimal battery performance, but can be
stored between -10–55°C (14–31°F) for short periods
of time.
Inlet O-ring (REF 66800603)
To ensure the canister seal is secure, the device inlet
port O-ring should be replaced after each patient use
as the O-ring can become worn over time, potentially
creating a source of air leak that may impact alarm
functionality.
1.
1.
Returning device
Prior to returning the device to your Smith & Nephew
authorized representative, device must be cleaned
according to the steps outlined under the cleaning
section of this user manual.
To replace the device inlet port O-ring, the
existing O-ring must be carefully removed using
a plastic removal tool, ensuring that the inlet
connector is not damaged during removal.
Device should be returned within the original packaging.
27
EN
Electromagnetic compatibility RENASYS™ GO (REF 66800164)
This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2001. These limits and
test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a
typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation.
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level
Electromagnetic environment – guidelines
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±2 kV for power supply
lines
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV line to line
±2 kV line to earth
Mains power quality should be that of a
typical commercial or hospital environment
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
>95% for 10ms
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the device requires continued
operation during power mains interruptions,
it is recommended that the device be
powered from an uninterruptable power
supply or battery
±1 kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital environment
Not applicable
60% for 100ms
30% for 500ms
>95% for 5000ms
NOTE UT is the a.c. mains voltage prior to application of the test level
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Conducted RF
IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment
Portable and mobile RF communications
equipment should be used no closer to
any part of device, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 √P
d = 1.2 √P (80 MHz to 800 MHz)
d = 2.3 √P (800 MHz to 2.5 GHz)
NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the device is used exceeds 3V/m, the
device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
28
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is
the recommended separation distance
in meters (m). Field strengths from fixed
RF transmitters, as determined by an
electromagnetic site survey, a should be less
than the compliance level in each frequency
rangeb. Interference may occur in
the vicinity of equipment marked
with the following symbol:
EN
Guidance and manufacturer’s declaration – electromagnetic emissions RENASYS™ GO (REF 66800164)
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidelines
RF emissions CISPR 11
Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Not Applicable
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Comply
The device is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
WARNING: The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use
is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
Recommended separation distances between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m):
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.0
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
29
EN
Specifications
Pressure
Setting
40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200mmHg:
tolerance +/- 10 mmHg
Maximum
200mmHg
Power requirements
Device input voltage
21 VDC
Device input power
36 Watts
Mains adapter
Smith & Nephew REF 66800161
Input: 100–240VAC, 50/60HZ, 0.9A
Output: 21VDC, 1.71A, 36W
Fuses
Internal electronic fuse, not user changeable
Power cord
Length: 4.5m maximum (Class I)
Dimensions
7 x 8.3 x 3.5in. / 175 x 210 x 85mm
Weight
2.4lbs / 1.1 kg
Operating time
~ 20 hours (therapy)
Type
Lithium ion
Charging time
~ 3 hours
Battery
Safety protection
Protection against electric shock
Class I
Patient protection
Type BF
Ingress protection
IP2X
Environmental
Storage and transport
14 to 131°F / -10 to 55°C
Operational temperature
41 to 95°F / 5 to 35°C
Relative humidity
30% to 70% RH
Atmospheric pressure
700 mbar to 1,060 mbar
Compliance
Standards
UL 60601-1
IEC 60601-1
IEC 60601-1-2CAN/CSA C22.2 No. 601.1
30
EN
Caution statements
In order to ensure safe and proper performance, the
following conditions must be met:
• All assembly, operation, adjustment, modification,
maintenance and/or repair should be carried out
by qualified personnel authorized by
Smith & Nephew.
• No modification of this equipment is allowed.
• If using Class I Power Supply (REF 66800161):
To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with
protective earth.
• Use only the AC mains power cord provided with
the device to prevent the potential for electrical
shock hazard.
• If power cord is damaged, wires are frayed or
exposed, do not use power cord. Contact your
Smith & Nephew representative for a replacement
cord.
• If the device is damaged, the performance could
be affected; Do not use the device. Contact your
Smith & Nephew authorized representative.
• When necessary, the device may be isolated from
AC mains power by removing the detachable AC
mains power adapter cord.
• The electrical installation of the room must comply
with the appropriate electrical wiring standards.
• The product must be used in accordance with this
user manual and all applicable labeling.
Failure to comply with these conditions will void any
pertinent warranties.
This user manual is not intended as a guarantee or
warranty. It is intended only as a guide. For medical
questions please consult a physician. For additional
product information, or a specific product question,
please refer to the numbers listed in the NPWT
Customer Care Details section of this user manual.
31
EN
LIMITED WARRANTY;
LIMITATION OF REMEDIES/LIABILITY:
Device
RENASYS™ NPWT electromechanical devices
(inclusive of the power
cord and power supply)
The Smith & Nephew negative pressure wound care
electro-mechanical device (“Device”) is warranted
against defects in workmanship and materials for the
warranty period specified below (“Warranty Period”).
Smith & Nephew reserves the right to discontinue
any Device or change any Device’s specifications or
designs from time to time. For any Device that fails to
meet the foregoing warranty, this warranty provides
and is restricted to replacement or repair (onsite
service not included) as elected by Smith & Nephew
in its sole discretion. If Smith & Nephew replaces a
Device under this warranty and requests Customer
to return the Device that was replaced, Customer will
be invoiced, at Smith & Nephew’s then current list
price, for the replacement Device if Customer does
not return the replaced Device within thirty (30) days
after Smith & Nephew’s shipment of the replacement
Device. This warranty does not cover and is voided
by any of the following: (i) a warranty claim not made
within the first to occur of expiration of the Warranty
Period or thirty (30) days following the failure of the
Device to perform as warranted; (ii) a Device packaged
or labeled by someone other than Smith & Nephew
or its authorized agents; (iii) a Device not used in
compliance with the specifications, instructions or
claims for use of the Device; (iv) a Device used in
conjunction with disposables, accessories or any other
products not specified for use with the Device; (v) a
Device used in conjunction with expired or reprocessed
disposables, accessories or other products specified
for use with the Device; (vi) modification of the Device;
(vii) damage due to misuse, reprocessing, alteration,
unauthorized repair or negligent handling or damage
due to lack of care by the owner, user, or handler of the
Device including but not limited to storage, handling
or cleaning; and (viii) any other damage inflicted to a
Device by the owner, user or handler. This warranty
applies only to the original buyer from Smith & Nephew
or its authorized distributor and is not transferable.
THIS WARRANTY IS THE SOLE WARRANTY OF
SMITH & NEPHEW. ALL OTHER WARRANTIES OF ANY
KIND OR DESCRIPTION WHATSOEVER, INCLUDING
WARRANTIES OF MERCHANTABILITY, SATISFACTORY
QUALITY AND FITNESS FOR A PARTICULAR PURPOSE,
EXPRESSED OR IMPLIED, ARE EXCLUDED TO THE
FULLEST EXTENT PERMITTED BY LAW.
Warranty Period
Two (2) years from date
of delivery to original
buyer
CUSTOMER’S SOLE REMEDY, AND SMITH & NEPHEW’S
SOLE LIABILITY, FOR ANY CLAIM WILL BE THE
REPAIR OR REPLACEMENT BY SMITH & NEPHEW
AS PROVIDED FOR IN THIS WARRANTY. EXCEPT
FOR THIS LIMITED LIABILITY OF SMITH & NEPHEW,
SMITH & NEPHEW UNDER NO CIRCUMSTANCES
WILL BE LIABLE FOR ANY (A) CLAIM, FOR DAMAGES
OR OTHERWISE, WHETHER ARISING FROM BREACH
OF CONTRACT, TORT (INCLUDING NEGLIGENCE)
OR OTHERWISE, AND WHETHER OR NOT BASED
ON OR FLOWING DIRECTLY, INDIRECTLY OR AS A
CONSEQUENCE OF A WARRANTY CLAIM, BREACH
OF CONTRACT, A TORT, BREACH OF LAW, OR
ANY OTHER CAUSE OR LEGAL THEORY, OR (B)
DIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL
DAMAGES, LOSSES OR EXPENSES ARISING FROM
THIS AGREEMENT OR ITS PERFORMANCE OR LACK
THEREOF, OR IN CONNECTION WITH THE SALE
OR USE OF, OR INABILITY TO USE, THE DEVICE,
INCLUDING BUT NOT LIMITED TO, LOSS OF PROFIT
OR ANTICIPATED SAVINGS, LOSS OF ANTICIPATED
PROFIT, COST OF COVER FOR REPLACEMENT OR
ALTERNATIVE PRODUCT, ECONOMIC LOSS, LOSS
OF DATA, WASTED EXPENDITURE OR LOSS OF
REPUTATION OR GOODWILL.
32
EN
Global customer assistance
For more information regarding RENASYS™ GO, or for additional customer assistance, please refer to
Smith & Nephew customer care center details below:
Australia
Smith & Nephew Pty Ltd.
315 Ferntree Gully Road
PO Box 242
Mount Waverley
Victoria 3149
Tel: +61 3 8540 6777
Fax: +61 3 9544 5086
Austria
Smith & Nephew GmbH
Concorde Business Park C3
Österreich
A-2320 Schwechat
Tel: +43 1 70 79102
Fax: +43 1 70 79101
[email protected]
Belgium
Smith & Nephew SA-NV
Hector Henneaulaan 366
1930 Zaventem
Tel: +32 2 702 2911
Fax: +32 2 702 2904
[email protected]
Canada
Smith & Nephew Inc.
2250 Alfred Nobel Boulevard
St. Laurent, Quebec H4S 2C9
Tel: 1 800 463 7439
Fax: 1 800 671 9140
Denmark
Smith & Nephew A/S
Slotsmarken 14
2970 Hoersholm
Tel: +45 4580 6100
Fax: +45 4580 6151
[email protected]
Finland
Smith & Nephew Oy
Äyritie 12 C
01510 Vantaa
Tel: +358 (0)207 866 300
Fax: +358 (0)207 866 320
France
Smith & Nephew SAS
Espace Novaxis
25 Blvd. Marie et Alexandre Oyon
72019 Le Mans Cedex 2
Tel: (33) 02 43 83 23 23
Fax: (33) 02 43 83 24 18
[email protected]
Germany
Smith & Nephew GmbH
Wound Management
Osterbrooksweg 71
D-22869 Schenefeld
Tel: +49 (040) 87 97 44 0
Fax: +49 (040) 87 97 44 375
[email protected]
Ireland
Smith & Nephew Healthcare Ltd.
Healthcare House
101 Hessle Road
Hull HU3 2BN
Customer Care: 01276 9700
Fax: 01276 4970
[email protected]
24hr Clinical Support: 1800 303622
Italy
Smith & Nephew
Wound Management
Via de Capitani, 2A
23864 Agrate Brianza (MB)
Tel: 800 393 060 (numero verde attivo 8.30-18.00)
039 6094224
Fax: 039 6094274
Centro Assistenza Clienti:
[email protected]
Japan
Smith & Nephew
Wound Management
Tokyo Warehouse Center C-3F
3-5-1, Rinkai-cho, Edogawa-ku, Tokyo
134-0086 Japan
Tel: 81-03-5667-2166
xxx
EN
Netherlands
Smith & Nephew B.V.
Postbus 525
2130 AM Hoofddorp
Bezoekadres:
Kruisweg 637
2132 NB Hoofddorp
Tel.: 020-654 39 99
Fax: 020-654 20 99
[email protected]
New Zealand
Smith & Nephew Limited
PO Box 442
Shortland Street
Auckland 1140
Tel: +64 9 828 4059
Fax: +64 9 820 2866
Norway
Smith & Nephew A/S
Postboks 224
1379 Nesbru
Besøksadresse:
Nye Vakåsvei 64
1395 Hvalstad
Tel: +47 66 84 20 20
Fax: +47 66 84 20 90
[email protected]
Portugal
Smith & Nephew, Lda.
Parque Tejo
EN 10, Km 131
2625-445 Forte da Casa
Tel: +351 21 446 0650
Fax: +351 21 446 0679
South Africa
Smith & Nephew (Pty) Ltd.
PO Box 92
Pinetown 3600
Tel: +27 (0)31 242 8111
Fax: +27 (0)31 242 8120
Spain
Smith & Nephew SAU
Fructuós Gelabert 2 y 4
08970 Sant Joan Despí
Barcelona
Tel: +34 93 373 73 01
Fax: +34 93 373 7453
Sweden
Smith & Nephew AB
Kråketorpsgatan 20
PO Box 143
431 22 Mönldal
Tel: +46 31 746 58 00
Fax: +46 31 87 05 32
Switzerland
Smith & Nephew AG
Glutz Blotzheim-Strasse 1
4502 Solothurn
Tel: +41 32 624 56 60
Fax: +41 32 624 56 81
Turkey
Smith & Nephew Ltd. Şti.
Orkide Sokak NO:8/E
Bahçeköy 34473
Istanbul Turkey
Tel: +90 212 226 22 55
Fax: +90 212 226 44 47
[email protected]
United Arab
Emirates
Smith & Nephew FZE
Level 4
National Bank of Abu Dhabi Building
Dubai Health Care City
PO Box 9715 Dubai
Tel: +971 4 429 9111
Fax: +971 4 429 9100
United Kingdom
Smith & Nephew Healthcare Ltd.
Healthcare House
101 Hessle Road
Hull HU3 2BN
Customer Care: 01482 673848
Fax: 01482 222206
[email protected]
24hr Clinical Support: 1800 9155394
United States
Smith & Nephew, Inc.
970 Lake Carillon Drive
St. Petersburg, FL 33716
Tel: 1 800 876 1261
Fax: 727 392 6914
[email protected]
xxx
Smith & Nephew, Inc.
970 Lake Carillon Drive, St. Petersburg, FL 33716, USA
Smith & Nephew Medical Ltd.
Hull HU3 2BN
England
www.smith-nephew.com
www.globalwoundacademy.com
Customer Care Center
1 800-876-1261
T 727-392-1261
F 727-392-6914
66800753
only
©2014 Smith & Nephew
™Trademark of Smith & Nephew
Certain marks Reg. US Pat. & TM Off.
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